公司成立不到5年，已构建起涵盖AI诊断、高端创新器械及进口替代产品的梯度化管线，展现出优异 的以临床需求驱动的系统化创新能力。其全国唯一的脉动式介入左心室辅助装置等产品，具备重大的 临床价值。 "我们坚信，悦唯医疗凭借其扎实的临床根基、全面的产品矩阵及高效的转化能力，必将成长为心血 管器械领域的领军企业。本次投资旨在助力公司加速产品研发与市场拓展，共同推动中国高端医疗器 械的自主创新与产业化进程。" 打造更符合中国的一线临床应用心脏外科产品。 本文为IPO早知道原创 作者｜ 罗宾 微信公众号｜ipozaozhidao 据IPO早知道消息，近日，北京悦唯医疗科技有限责任公司（下称"悦唯医疗"）宣布完成近亿元B轮 融资，由倚锋资本领投，北商资本、渤海创富跟投，凯乘资本担任独家财务顾问。通过本轮融资赋 能，悦唯医疗将继续强化在心血管外科及其他外延领域的研发创新与市场渗透能力，持续巩固其领先 地位。 悦唯医疗创立于2021年9月，公司基于创始团队长期的临床经历，挖掘临床需求，同时结合相关领 域发展现状，研发多款全球首创、国内首创或填补市场空白的医疗器械。目前公司已自研冠脉外科、 重症及体外循环两大产品线，包含近10款 ...

中证报中证网讯(记者齐金钊)日前，深圳汉诺医疗科技股份有限公司(简称"汉诺医疗")向上交所递交科 创板的上市申请获受理，公司拟采用科创板第五套上市标准登陆资本市场。作为国内首家实现体外膜肺 氧合(ECMO)系统获批上市的国产企业，汉诺医疗成立于2018年5月8日，是全球少数完成设备与耗材完 整布局的厂商之一。 以第五套上市标准"闯关"科创板 近年来，上交所通过制度优化，持续提升科创板对科技创新企业的包容性与适应性，使其更加契合科技 型企业的成长规律与发展需求。汉诺医疗此次申报科创板IPO，是上交所在重启第五套上市标准后，又 一家适用该标准的创新医疗（002173）器械企业。 财务表现方面，招股书显示，汉诺医疗正处于高速成长通道：公司营收从2023年的2983.11万元增长至 2024年的4930.88万元；2025年上半年，公司营收已达3735.53万元。报告期内，公司亏损也大幅收窄， 从2023年的3.41亿元收窄至2025年上半年的8227.32万元，反映出公司业务扩张与运营效率的同步提升。 公司的成长潜力也获得了资本市场的持续认可。成立以来，汉诺医疗已经完成了10轮融资，吸引包括道 彤投资、迈瑞医疗（3 ...

Core Insights - The Chinese high-end medical device industry is experiencing accelerated innovation due to regulatory measures such as the expansion of the innovation review green channel and the introduction of the "ranking and leading" mechanism [1][2] - The number of approved innovative medical devices in China has reached a historical high, with 65 approved in 2024 and 45 in the first half of 2025, marking an 87.5% year-on-year increase [2] - The domestic high-end medical device sector is making progress in localization, particularly in medical imaging, but still faces challenges in foundational research and reliance on imported components [3][4] Regulatory Measures - The National Medical Products Administration (NMPA) has implemented special reviews for innovative medical devices that are domestically created, internationally leading, and clinically valuable [1][6] - The NMPA is enhancing its legal standards and increasing support for research and development to expedite the market entry of innovative products [1][6] - An expert consultation mechanism has been established to guide companies through the regulatory process, ensuring that innovative medical devices meet safety and efficacy standards [6][7] Industry Progress - The domestic supply chain for medical imaging has improved, with significant advancements in the independent research and production capabilities of core devices [2][3] - Nearly half of the innovative medical devices approved in the first half of 2025 were non-powered devices and in vitro diagnostic (IVD) products, indicating a shift towards more advanced materials and technologies [5] - The NMPA has launched innovation cooperation platforms for artificial intelligence and biomaterials to facilitate the development and approval of cutting-edge medical devices [4][5] Challenges and Opportunities - Despite advancements, the industry still faces "bottleneck" issues in foundational research, software development, and reliance on imported key components [3][4] - The market for high-end medical devices is characterized by high R&D costs and low short-term profitability, which deters other industrial players from entering the sector [4] - New technologies in artificial intelligence and biomaterials present opportunities for further innovation in high-end medical devices [3][5]

Core Insights - The approval of innovative medical devices in China has reached a historical high, with 323 devices approved to date, reflecting a significant acceleration in regulatory innovation and support for high-end medical device development [1][2][5] Regulatory Developments - The National Medical Products Administration (NMPA) has implemented special reviews for innovative medical devices that are domestically created, internationally leading, and clinically valuable, aiming to optimize the review process [1][2] - The NMPA plans to enhance the legal and standard framework, increase support for research and development, and improve the efficiency of reviews and approvals [1][2] Industry Trends - The number of approved innovative medical devices has been increasing annually, with a 87.5% year-on-year growth in the first half of 2025 [2] - The domestic medical imaging industry has seen improvements in the supply chain and production capabilities, with many mid-to-low-end products achieving domestic substitution [2][3] Challenges in Domestic Production - Despite advancements, there are still significant challenges in foundational research, software development, and reliance on imported key components [3][4] - The overall market share of domestic high-end medical imaging equipment remains low, indicating ongoing dependency on foreign technology [3][4] Strategic Initiatives - The NMPA has established innovation cooperation platforms for artificial intelligence and biomaterials to facilitate the transformation of research into practical applications [5] - The Ministry of Industry and Information Technology and the NMPA have announced initiatives to focus on key materials and technologies to enhance domestic production capabilities [5] Expert Consultation Mechanism - The NMPA has introduced an expert consultation mechanism to guide innovative medical device companies through the development and approval process, ensuring comprehensive understanding of cutting-edge technologies [7][8] - The expert consultation process includes a diverse pool of approximately 2,500 experts across various medical and technical fields to support the review and evaluation of innovative products [8][9] Focus Areas for Future Development - Future research in artificial intelligence medical devices is expected to concentrate on wireless diagnostics, digital therapies, brain-machine interfaces, and flexible wearable devices [6]

Group 1 - The company reported a revenue of 224 million yuan for the first half of 2025, representing a year-on-year growth of 12.80% [1] - The net profit attributable to shareholders reached 32.67 million yuan, with a significant year-on-year increase of 92.02% [1] - The net profit after deducting non-recurring gains and losses was 20.81 million yuan, showing a remarkable growth of 2157.4% year-on-year [1] Group 2 - The company achieved comprehensive commercialization breakthroughs in its three energy platforms: "Radiofrequency + Cryo + Pulsed Field Ablation (PFA)" [1] - The approval of the PFA product from the affiliated company, Shangyang Medical, completed the company's commercial landscape [1] - The company’s self-developed PulseMagic pressure pulse catheter is in the product registration approval stage, expected to be approved within 2025 [1] Group 3 - The company has established a strong position as a domestic leader in the electrophysiology field, with over 1,000 hospitals covered and more than 80,000 surgeries completed [2] - The company’s Magbot magnetic navigation catheter and PathBuilder adjustable guiding sheath were selected for the 2025 high-quality development project of the Pudong New Area biomedicine industry [2] - International market revenue grew over 40% year-on-year, with successful entries into markets in Mexico, the UK, and Rwanda [2]

Core Viewpoint - The medical device sector is experiencing significant activity, with several companies seeing substantial stock price increases following positive regulatory news and government support for domestic innovation [1][3]. Group 1: Company Performance - Companies such as Sainuo Medical and Zhonghong Medical have seen their stock prices surge, with Sainuo Medical rising by 20.01% to 17.03 and Zhonghong Medical increasing by 19.99% to 16.21 [2]. - Other notable performers include Yangpu Medical, which rose by 10.86%, and Shangrong Medical, which increased by 9.90% [2]. Group 2: Regulatory Developments - Sainuo Medical's subsidiary received breakthrough medical device designation from the FDA for its COMETIU self-expanding intracranial drug-coated stent system, marking a significant milestone in the treatment of intracranial atherosclerotic stenosis [3]. - The National Medical Products Administration has approved new measures to support the innovation of high-end medical devices, which will benefit domestic manufacturers [3]. Group 3: Market Opportunities - New government procurement policies will exclude EU companies from participating in medical device purchases over 45 million yuan, creating opportunities for domestic manufacturers [3]. - The focus on high-end medical equipment and diagnostic instruments is expected to enhance the competitiveness and market share of companies with independent R&D capabilities [3]. - Companies with international market presence are likely to benefit from accelerated growth opportunities as domestic medical device firms expand globally [3].

Group 1 - Suzhou Meichuang Medical Technology Co., Ltd. has completed a Series B financing round of over 100 million yuan, with participation from various institutions including Suzhou Venture Capital and Sequoia China [1] - The company has raised over 300 million yuan in total financing within five months, highlighting its status as a capital focus in the high-end medical device sector [1] - The founder, Liu Wenjing, has 30 years of experience in the peripheral vascular and tumor intervention fields, emphasizing the importance of mastering core technologies for long-term success [3][4] Group 2 - Meichuang Medical has successfully overcome the technical challenges associated with medical-grade ePTFE material, becoming the first domestic company to achieve large-scale production [4] - The company is focused on three main areas: peripheral vascular intervention, tumor intervention, and blood access maintenance, with a diverse product line including vascular/non-vascular stents and artificial blood vessels [4] - The ePTFE tubing and membrane materials have completed the National Medical Products Administration documentation, clearing a significant hurdle for market entry [5] Group 3 - The recent financing will primarily support clinical trials for core products such as TIPs stents and artificial blood vessels, promoting domestic alternatives [5] - Investors express confidence in Meichuang Medical's growth potential, citing the founder's extensive experience and the company's innovative breakthroughs in ePTFE materials [5][6] - The company aims to enhance treatment accessibility through its proprietary ePTFE technology, addressing clinical needs and reducing reliance on expensive foreign suppliers [4][6]